EMA — authorised 18 December 2019
- Marketing authorisation holder: Janssen-Cilag International N.V.
- Status: approved
🇪🇺 Spravato in European Union
EMA authorised Spravato on 18 December 2019
Marketing authorisation
Spravato in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in European Union
Frequently asked questions
Is Spravato approved in European Union?
Yes. EMA authorised it on 18 December 2019.
Who is the marketing authorisation holder for Spravato in European Union?
Janssen-Cilag International N.V. holds the EU marketing authorisation.